BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    RELIANCE FAMILY OF WASHER-DISINFECTORS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983068·posteriors; shade B4; size M; upper jaw

    Nitrile Glove Powder Free White

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HEMODIALYSIS CONCENTRATES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COULTER® LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·February 28, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 4, 2011

    TPS HANDPIECE CORD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code EIA·August 6, 2014

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024